Search by Drug Name or NDC

NDC 00487-5901-99 S2 11.25 mg/.5mL Details

S2 11.25 mg/.5mL

S2 is a RESPIRATORY (INHALATION) SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Nephron SC, Inc.. The primary component is RACEPINEPHRINE HYDROCHLORIDE.

Product Information

NDC	00487-5901
Product ID	0487-5901_b8a789aa-55e6-6497-e053-2a95a90a4169
Associated GPIs	44202060012530
GCN Sequence Number	054686
GCN Sequence Number Description	racepinephrine HCl VIAL-NEB 2.25 % INHALATION
HIC3	A1D
HIC3 Description	GENERAL BRONCHODILATOR AGENTS
GCN	22696
HICL Sequence Number	025002
HICL Sequence Number Description	RACEPINEPHRINE HCL
Brand/Generic	Brand
Proprietary Name	S2
Proprietary Name Suffix	n/a
Non-Proprietary Name	racepinephrine hydrochloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	RESPIRATORY (INHALATION)
Active Ingredient Strength	11.25
Active Ingredient Units	mg/.5mL
Substance Name	RACEPINEPHRINE HYDROCHLORIDE
Labeler Name	Nephron SC, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00487-5901-99 (00487590199)

Pricing Information	N/A
NDC Package Code	0487-5901-99
Billing NDC	00487590199
Package	30 POUCH in 1 CARTON (0487-5901-99) / 1 VIAL, SINGLE-USE in 1 POUCH / .5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date	2000-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL dd1b35c7-b23b-4b95-8162-df3d263fe32e Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 0.5 ml)

Racepinephrine, USP 11.25 mg (as 13.5 mg of Racepinephrine HCl, USP).

Purpose

Bronchodilator

Uses

For temporary relief of mild symptoms of intermittent asthma:

Wheezing
Tightness of chest
Shortness of breath

Warnings

Asthma alert

Because asthma may be life threatening, see a doctor if you:

Are not better in 20 minutes
Get worse
Need more than 12 inhalations in 24 hours
Use more than 9 inhalations in 24 hours for 3 or more days a week
Have more than 2 asthma attacks in a week

These may be signs that your asthma is getting worse.

Do not use:

Unless a doctor said you have asthma
If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.
If product is brown in color or cloudy

Ask a doctor before use if you have:

Ever been hospitalized for asthma
Heart disease
High blood pressure
Diabetes
Thyroid disease
Seizures
Narrow angle glaucoma
A psychiatric or emotional condition
Trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are:

Taking prescription drugs for asthma, obesity, weight control, depression, or psychiatric or emotional conditions.
Taking any drug that contains phenylephrine, pseudoephedrine, ephedrine, or caffeine (such as for allergy, cough-cold, or pain).

Stop use and ask a doctor if:

Your asthma is getting worse (See Asthma alert)
You have difficulty sleeping
You have a rapid heartbeat
You have tremors, nervousness, or seizure

When using this product:

Your blood pressure or heart rate may go up. This could increase your risk of heart attack or stroke, which may cause death.

Your risk of heart attack or stroke increases if you:
- Have a history of high blood pressure or heart disease
- Take this product more frequently or take more than the recommended dose.
- Avoid foods or beverages that contain caffeine
- Avoid dietary supplements containing ingredients reported or claimed to have a stimulant effect.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine.
Do not use more than directed
For use in a hand-held rubber bulb nebulizer:

Add 0.5 ml (contents of one vial) of solution to nebulizer.
Adults and children 4 years of age and over:

1 to 3 inhalations not more often than every 3 hours.

Do not use more than 12 inhalations in 24 hours.

The use of this product by children should be supervised by an adult.
Children under 4 years of age: ask a doctor.

Other Information

Protect from light. Avoid excessive heat. Protect from freezing.
Store between 2°C and 25°C (36°F and 77°F).
How Supplied: S 2® Racepinephrine Inhalation Solution, USP 2.25% is supplied in 0.5 ml sterile unit-of-use vials.

NDC 0487-5901-99 30 vials, each vial in an individual foil pouch.

Inactive Ingredients

Ascorbic acid, citric acid, edetate disodium, water for injection.

Questions?

1-800-443-4313

Monday through Friday, 8:00 a.m. to 5:00 p.m. (Eastern Standard Time).

SPL UNCLASSIFIED SECTION

Manufactured By:

Nephron Pharmaceuticals Corporation

West Columbia, SC 29172

PACKAGE LABEL, PRINCIPAL DISPLAY PANEL

Principle Display - Pouch Label (Individually Wrapped Vial)

NDC 0487-5901-99

Principle Display - Carton (30 Individually Wrapped Vials)

NDC 0487-5901-99

INGREDIENTS AND APPEARANCE

S2

racepinephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0487-5901
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RACEPINEPHRINE HYDROCHLORIDE (UNII: 336096P2WE) (RACEPINEPHRINE - UNII:GR0L9S3J0F)	RACEPINEPHRINE	11.25 mg in 0.5 mL

Ingredient Name	Strength
Inactive Ingredients
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0487-5901-99	30 in 1 CARTON	01/01/2000
1		1 in 1 POUCH
1		0.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/01/2000

Labeler - Nephron SC, Inc. (079160190)

Name	Address	ID/FEI	Business Operations
Establishment
Nephron SC, Inc.		079160190	manufacture(0487-5901) , analysis(0487-5901) , pack(0487-5901) , label(0487-5901)

Revised: 1/2021

Document Id: b8a789aa-55e6-6497-e053-2a95a90a4169

Set id: dd1b35c7-b23b-4b95-8162-df3d263fe32e

Version: 10

Effective Time: 20210111

Search by Drug Name or NDC

NDC 00487-5901-99 S2 11.25 mg/.5mL Details

S2 11.25 mg/.5mL

Product Information

Package

Package Images

NDC 00487-5901-99 (00487590199)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL dd1b35c7-b23b-4b95-8162-df3d263fe32e Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each 0.5 ml)

Purpose

Uses

Warnings

Asthma alert

Directions

Other Information

Inactive Ingredients

Questions?

SPL UNCLASSIFIED SECTION

PACKAGE LABEL, PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?